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The Young Inventor’s Pathway: A Virtual Panel

June 1, 2016

By Alexander Nicholas, Program Officer, The Lemelson Foundation

Invention-based businesses create jobs, spark economic development, and hold unique potential for improving people’s lives. But this work is not easy. Inventors – especially young people who are just finishing their educations and starting businesses – face many obstacles. Their ultimate success rests not just on the strength of their inventions, but the soundness of their business plans and the support they’re able to garner at every turn.

I talked with three young biotechnology inventors about the process of identifying a pressing problem, coming up with an inventive solution, and transforming it into a self-sustaining business.

Given location and time challenges, our discussion was a virtual one, held over email, and unfolding over a few days in early April 2016. The resulting exchange provides valuable insights into the long and winding pathway from student to entrepreneur, and we hope it can inspire other fledgling inventors to choose this challenging but rewarding course.

LEMELSON FOUNDATION: Let’s start at the beginning. How do inventors like you identify the urgent societal needs that are most deserving of your attention? What’s the problem that your invention solves, and how did you get inspired to tackle it?

JOCELYN BROWN: Preterm birth is now the leading cause of death in children under five worldwide. Respiratory distress syndrome (RDS) is a common condition in premature newborns because the infant's lungs are not fully mature and tend to collapse. In the U.S., RDS is typically treated with a device called bubble Continuous Positive Airway Pressure (bCPAP), which provides a gentle stream of pressurized air into the patient's airway to keep the lungs inflated. But bCPAP technology can be costly and complex. Very few premature infants born in the developing world have access to effective bCPAP therapy.

I was inspired to create the Pumani bCPAP, a low-cost device for low-resource settings, during my undergraduate studies at Rice University when I traveled to Rwanda with a class of bioengineering and MBA students. We visited many neonatal wards and I witnessed firsthand babies struggling to breathe. Although these hospitals had oxygen therapy, and occasionally one expensive bCPAP device, there was no effective treatment for most of the premature newborns born in these hospitals. I became convinced of the need for low-cost bCPAP therapy and I decided to use my engineering skills to design an effective, affordable bCPAP device.

DAVID NARROW: Free-flap surgery, which moves soft tissue and reconnects arteries or veins, started more than 30 years ago. While this has been a tremendous advance, the risk of a blood clot forming in the newly connected vessels during the postoperative period is ever-present. This problem is not unique to free-flap surgery, and extends into solid organ transplantation, vascular bypass, and vascular access procedures. Post-operative clots can result in catastrophic surgical failures costing up to $500,000 if they are not detected in a timely manner.

Our product EchoSure was designed to provide reliable, early detection of thrombosis. EchoSure detects changes in blood flow using Doppler ultrasound. The inspiration came from my co-founder and Hopkins microsurgeon, Dr. Devin O’Brien-Coon. This problem of clotting and its potentially life-threatening results was something that he faced on a routine basis, and knew that there could be a better way.

TRICIA COMPAS-MARKMAN: Each year, over 255 million people are affected by natural disasters. Whether it’s in Haiti, the Philippines, or New Orleans, survivors often do not have access to clean water and they face life-threatening waterborne illnesses. DayOne Response Inc. addresses this global need through our flagship product, the DayOne Waterbag, a U.S. EPA-approved, ten-liter water backpack that empowers people easily and quickly purify heavily-contaminated water into clean drinking water in 30 minutes. A single Waterbag can provide a family with a minimum of two months of water, bridging the gap between disasters and long-term water provision.

My own motivation for working on clean drinking water solutions started in my undergraduate years, when I co-founded the Cal Poly-San Luis Obispo university chapter of Engineers without Borders. It was through this experience that I was exposed to what clean drinking water can mean to individuals, children, families, and overall communities. Furthermore, during Graduate studies, I worked with Dr. Tryg Lundquist to design and develop what is now the DayOne Waterbag technology. Shortly after graduating, I founded DayOne Response.

LEMELSON: Inventors need support from different people and organizations as they work to develop their products and business. What kind of support did you receive along the way?

COMPAS-MARKMAN: After working in Northern Thailand with Engineers without Borders, I decided to pursue my master’s in civil/environmentalengineering to dive more into water treatment. I spent those two years developing and co-inventing the Waterbag technology. My engineering thesis professor, Dr. Tryg Lundquist, encouraged me to use the resources at my university – collaborate with the plastics department to learn how to seal and design plastics, work with the manufacturing department to understand how things are made, and partner with a graphics student to design pictographic instructions. Engaging all these disciplines and perspectives were key in creating a low-tech but highly designed solution.

NARROW: The first organization that had faith in EchoSure and the Sonavex team was TEDCO, the Technology Development Corporation based in Maryland. They enabled our team to reach important early technical milestones, and their staff was incredibly supportive as we formed the business. Together with other early supporters, TEDCO paved the way for Sonavex to target the NIH and NSF for larger grants, and enabled private investors to grow the business. Bob Falotico, Ph.D. formerly at Johnson & Johnson was an instrumental partner; his expertise and network in bioabsorbables enabled us to find a manufacturer to suit our technical requirements.

BROWN: The Pumani bCPAP design, development, clinical evaluation, regulatory clearance, and commercial production has been a six-year collaboration among engineering, design, and clinical teams in the U.S. and Malawi. The 3rd Stone Design team initially redesigned the Pumani bCPAP prototype developed by the Rice University team. After managing the production of over 100 Pumani bCPAP devices for distribution in Malawi, 3rd Stone Design licensed the technology in 2014 to bring it to market. Over the past two years, 3rd Stone Design has shepherded the Pumani through the regulatory process, prepared the product for manufacture, and is now commercially producing and selling it to customers in over 18 countries around the world.

LEMELSON: Being an inventor entrepreneur often involves dealing with setbacks, learning from them, and making strategic shifts to improve products and business plans. What unforeseen obstacles have you faced in the arc of your invention process? What can inventors learn from missteps or failures?

NARROW: The first iteration of our EchoMark implant performed horribly; not only did we have tremendous manufacturing issues but the product did not maintain its desired features in an in vivo environment. We had to scramble to redesign our product and find the financial resources to “take a step back,” but we had to identify a manufacturer who could produce a part that met our criteria – a very challenging task. By leveraging our network, we were able to find an expert to connect us with the appropriate partner to successfully produce our product. The lessons I’ve learned are: (1) you must accept that your technology may have to change; (2) that is OK!; and (3) use your network to supplement your knowledge and capabilities.

BROWN: It is incredibly challenging to produce a medical device that is low-cost, user-friendly, optimally-designed, as well as meets regulatory standards. Throughout the Pumani design and development, our team continually evaluated how to produce a durable, easy-to-use device that was still one-third of the cost of any other bCPAP on the market. It's important to focus on the users who you are ultimately designing for: What is their acceptable price point? What features do they absolutely require vs. what do they find unnecessary? Do they actually like using the product, and would they recommend it to their colleagues?

COMPAS-MARKMAN: One of the biggest challenges I faced in the invention process was that it took two years to develop the technology, when my initial expectations were it would take three months. I spent hundreds of hours at the lab, designing, developing, failing, and starting again, learning as I went. It wasn’t a specific moment, but rather a series of small failures that led to finding the correct solution.

One of the major lessons I learned early on and that continues to stand true is that design is only 10% of the overall solution. There are many factors including cultural circumstances, user experience, financing, ease-of-use, distribution, supply chain, maintenance, costs, and overall business models. For me as an engineer and as the CEO of DayOne Response, all of these factors play an important role in our strategy.

LEMELSON: The Lemelson Foundation supports an invention ecosystem capable of having a positive and meaningful impact on people’s lives. What impact has your company had?

BROWN: We estimate that over 2,500 patients in Malawi have been treated since the product’s introduction in 2012. In addition, more than 300 Pumani bCPAP devices have been distributed to over 50 hospitals in over 18 countries in Sub-Saharan Africa, Southeast Asia, and Latin America. Many of these hospitals now, for the first time, have effective treatment for their premature infants in respiratory distress.

COMPAS-MARKMAN: Over the past year, DayOne has expanded deployments in over 20 countries for immediate disaster relief, cholera preparedness, and seasonal rain events in West Africa, and typhoon response in Southeast Asia. We are working with wonderful partners like AmeriCares, World Vision International, and CARE to extend our reach.

We also continually hear that the Waterbag is changing the way people collect and consume water. In Cote d’lvoire, for example, deadly outbreaks of cholera are a continual problem because people drink unclean water. One community member using the DayOne Waterbag noted: “When I see the dirt at the bottom of the bag, I said [to] myself I will never again drink the water directly from the pond.” We are very proud of creating this kind of change.

NARROW: Sonavex is a development stage medical device company that does not yet have FDA clearance but we’re already creating jobs. Our team is proud to have three full-time employees.

LEMELSON: Final question. What are you hoping to do with your company in the future? What’s on the horizon

COMPAS-MARKMAN: DayOne Response is continuing to scale global efforts to provide safe water for disaster response and longer-term recovery. We are now also addressing water needs here at home in the U.S. We recently launched a domestic campaign that will expand our preparedness solutions for earthquakes, hurricanes, and floods, or for those eager for outdoor adventure. Additionally, we are demonstrating the energy efficiency of the Waterbag to the U.S. military for troop needs and humanitarian assistance.

NARROW: Sonavex is thrilled about our plan to launch EchoSure in numerous markets where it can add tremendous value to surgical patients and hospitals alike. Our company is also working on new products that support our mission of deskilling ultrasound and bringing it to the point of care before, during, and after surgery.

BROWN: 3rd Stone Design is developing partnerships with medical distributors around the world to provide the Pumani bCPAP to hospitals and patients in need. In addition, 3rd Stone Design is working on a number of other maternal and newborn health technologies, including a cervical cancer screening device and a solar-powered, portable vaccine refrigerator. We are continually motivated to see our products used in the real world, rather than sitting on a lab bench. The Pumani bCPAP is a great reminder to our team of the impact that truly needed global health products can have.